Near-infrared Spectroscopy-based Neurofeedback as Adjunct to Mindfulness-Oriented Recovery Enhancement in Persons With Chronic Pain

Opioid Use Clinical Trial

Official title:

Near-infrared Spectroscopy-based Neurofeedback as Adjunct to Mindfulness-Oriented Recovery Enhancement in Persons With Chronic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04902339
• Other study ID #: IRB_00129302
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: August 30, 2023

Study information

• Verified date: July 2023
• Source: University of Utah
• Contact: Research Coordinator
• Phone: 8015813826
• Email: Utahpainstudy[@]utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim of this pilot trial is to enhance the efficacy of the Mindfulness-Oriented Recovery Enhancement (MORE) intervention by adding neurofeedback (NF) of the Orbitofrontal Cortex (OFC) as an adjunct to the savoring component of MORE. We hypothesize that the use of NF to train OFC responses during savoring will amplify patients' ability to savor and thereby increase brain responsivity to natural rewards; such enhanced reward responding will in turn be associated with improvements in clinical outcomes (e.g., pain, analgesic use).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: August 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. =18 years of age,

2. ability to understand and speak the English language

3. current chronic pain-related diagnosis

Exclusion Criteria:

1. mindfulness training experience (e.g., participation in MBSR/MBRP)

2. neurofeedback experience

3. current cancer diagnosis

4. having a psychiatric or medical condition that precludes the ability to provide informed consent or participation in outpatient treatment (e.g., psychosis, mania, acute intoxication)

5. suicidal ideation with a plan in the past week, or a suicide attempt in the past 3 months

6. unwilling, unable, or unlikely to complete study procedures (e.g., planned major surgery, anticipated move, travel barrier)

7. communication or cognitive impairment that limits participation in group treatment or study procedures

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome
• Opioid Use

Intervention

Behavioral:
• Mindfulness-Oriented Recovery Enhancement
8 weeks of therapy integrating mindfulness, reappraisal, and savoring skills.

Other:
• Neurofeedback
Near-infrared spectroscopy neurofeedback during savoring practice.

Behavioral:
• Supportive Psychotherapy
8 weeks of supportive, process-oriented psychotherapy.

Locations

Country	Name	City	State
United States	Center on Mindfulness and Integrative Health Intervention Development	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood oxygenation level dependent (BOLD) signaling	Changes in blood oxygenation levels to reward cues will be assessed, and planned comparisons will be performed between subjects receiving MORE+NF vs the control conditions.	From baseline to immediately after the intervention.
Secondary	Opioid misuse	Scores on Current Opioid Misuse Measure, with higher scores indicating higher opioid misuse (min 0, max 68)	From baseline to 3-month follow-up.
Secondary	Chronic pain symptoms	Chronic pain symptoms will be measured with the Brief Pain Inventory, where higher scores indicate worse pain (min 0, max 10).	From baseline to 3-month follow-up.
Secondary	Opioid dose	Opioid dose as assessed with Timeline Followback Procedure	From baseline to 3-month follow-up.
Secondary	Savoring	Savoring as measured by the Brief Savoring Inventory, with higher scores indicating higher savoring (min 4, max 20)	From baseline to 3-month follow-up.
Secondary	Distress	Emotional distress measured by the Depression Anxiety Stress Scale-21, with higher scores indicating higher distress (min 0, max 63)	From baseline to 3-month follow-up.
Secondary	Self-transcendence	Self-transcendence measured by Nondual Awareness Dimensional Assessment, with higher scores indicating higher self-transcendence (min 13, max 65)	From baseline to 3-month follow-up.
Secondary	Pleasant sensation ratio	Pleasant sensation ratio as measured by Sensation Manikin, a measure comprised of a visual body map to demonstrate the location and distribution of sensations.	From baseline to immediately after intervention.
Secondary	Opioid craving	Opioid craving measured by numeric rating scale, with higher scores indicating worse craving (min 0, max 10)	From baseline to 1-month follow-up.
Secondary	Positive affect	Positive affect measured by numeric rating scale, with higher scores indicating higher positive affect (min 0, max 10)	From baseline to 1-month follow-up.
Secondary	Pleasure ratings	Positive affect measured by numeric rating scale, with higher scores indicating higher pleasure (min 0, max 10)	From baseline to immediately after intervention.